Zyban Tablets

What is Zyban?

Zyban contains the active substance bupropion hydrochloride. It belongs to a class of medicines that are not nicotine-based. Unlike nicotine replacement therapies (NRTs) like patches or gum, Zyban works by targeting the brain's chemistry to help manage the symptoms of nicotine withdrawal.

Mechanism of Action

While the exact mechanism for smoking cessation is not fully understood, it is believed that bupropion works by influencing neurotransmitters in the brain, such as noradrenaline and dopamine. These chemicals are involved in reward pathways and mood regulation. By modulating these pathways, Zyban can help to reduce the severity of nicotine cravings and withdrawal symptoms, making it easier to quit smoking.

What is Zyban Used For?

Zyban is indicated as a treatment to aid smoking cessation for adults. It is prescribed for individuals who are motivated to quit and are participating in, or have access to, a motivational support programme, such as the NHS Stop Smoking Service.

Target Patient Population

It is intended for adult smokers (18 years and over). The treatment is most effective when the user is fully committed to quitting.

Before Using Zyban

Before starting treatment with Zyban, a thorough medical assessment is necessary. Your clinician will need to know your full medical history.

Medical History Assessment Checklist

Inform your doctor if you have or have ever had any of the following:

• Fits (seizures) or epilepsy
• An eating disorder (e.g., bulimia, anorexia)
• Head injury or brain trauma
• Liver or kidney problems
• High blood pressure
• Bipolar disorder or other mental health conditions (e.g., depression, psychosis)
• Heart problems (e.g., Brugada syndrome, heart attack, irregular heartbeat)
• Diabetes

Zyban Contraindications

Do NOT take Zyban if any of the following apply to you:

Absolute Contraindications

• Allergy: You are allergic to bupropion or any other ingredient of Zyban.
• You have a condition that causes seizures (e.g., epilepsy) or a history of seizures.
• You have or have had an eating disorder (e.g., bulimia or anorexia nervosa).
• You have a brain tumour.
• You have severe liver cirrhosis.
• You are currently taking or have recently (within 14 days) taken a type of antidepressant known as a monoamine oxidase inhibitor (MAOI).
• You have bipolar disorder.
• You are a heavy drinker and are suddenly stopping alcohol, or are planning to stop while taking Zyban.
• You have recently stopped taking sedatives (e.g., benzodiazepines) or are planning to stop them while taking Zyban.

Special Population Considerations

Elderly (Over 65)

• May be more sensitive to side effects
• A lower dose (once daily) is often recommended
• Closer monitoring is required

Renal or Hepatic Impairment

• Not recommended in severe liver cirrhosis
• In mild to moderate liver or kidney disease, a lower dose (once daily) is recommended
• Use with caution and under close medical supervision

Children and Adolescents (Under 18)

• Zyban is not recommended for use in individuals under 18 years of age

Zyban and Other Medicines

It is crucial to inform your doctor about all medicines you are taking, including prescription, over-the-counter, and herbal remedies.

High-Risk Medication Combinations (Increased Seizure Risk)

• Antidepressants and antipsychotics
• Stimulants or appetite suppressants
• Theophylline (for asthma)
• Tramadol (strong painkiller)
• Steroids (oral/injected)
• Medicines for malaria
• Some antibiotics (quinolones)
• Some sedating antihistamines

Other Significant Interactions

Zyban can interact with many other drugs, including those for depression (e.g., SSRIs like paroxetine), Parkinson's disease, epilepsy (e.g., carbamazepine), HIV (e.g., ritonavir), and heart conditions (e.g., beta-blockers like metoprolol). These interactions can lead to side effects or reduce the effectiveness of either medicine.

Tamoxifen

Zyban may make tamoxifen (used for breast cancer) less effective. Your doctor may recommend an alternative smoking cessation treatment.

Pregnancy & Breastfeeding

Pregnancy

• Do not take Zyban if you are pregnant, think you may be pregnant, or are planning to have a baby
• Some studies have reported an increased risk of heart defects in babies exposed to bupropion
• Always seek advice from your doctor

Breastfeeding

• The ingredients of Zyban pass into breast milk
• Do not take Zyban if you are breastfeeding
• Ask your doctor or pharmacist for advice

Driving & Machine Operation

• Zyban may cause side effects such as dizziness, light-headedness, or difficulty concentrating
• These effects could impair your ability to drive or operate machinery safely
• Do not drive or use machines if you are affected by these symptoms

Zyban Ingredients

Active Ingredient

• Each tablet contains 150 mg of Bupropion Hydrochloride

Other Ingredients (Excipients)

• Tablet core: Microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium stearate
• Tablet coating: Hypromellose, macrogol 400, titanium dioxide (E171), carnauba wax
• Printing ink: Hypromellose, iron oxide black (E172)

How to Use Zyban

Always take Zyban exactly as prescribed by your doctor.

Key Steps

1. Start while smoking: Begin taking Zyban while you are still smoking
2. Set a date: Set a 'Target Stop Smoking Day' for during your second week of treatment
3. Swallow whole: Do not chew, crush, or split the tablets, as this can lead to a rapid release of the medicine and increase the risk of side effects, including seizures

Zyban Dosage Guidelines

Standard Treatment Schedule

Lower Dose for Specific Patients

For patients over 65, or those with kidney/liver problems or a higher risk of seizures, the maximum recommended dose is one 150 mg tablet once a day.

Administration Instructions

• Take the tablets at least 8 hours apart
• To reduce the risk of insomnia, avoid taking your dose too close to bedtime
• Zyban can be taken with or without food

Missed Dose Management

If you forget to take a dose, wait and take your next tablet at the usual time. Do not take a double dose to make up for the forgotten one.

Overdose Information

Taking more than the prescribed dose of Zyban significantly increases the risk of seizures and other serious side effects.

If you have taken an overdose

• Do not delay
• Contact your doctor immediately or go to the nearest hospital emergency department

Zyban Side Effects

Like all medicines, Zyban can cause side effects, although not everybody gets them.

Serious Side Effects - Stop taking Zyban and seek immediate medical help if you experience:

• Seizures (fits) (See Critical Safety Warning)
• Serious Allergic Reactions: Signs include skin rash (especially with blisters, mouth sores, or red eyes), swelling of the face, lips, tongue or throat, difficulty breathing, or collapse
• Mental Health Changes: Thoughts of harming or killing yourself, depression, anxiety, agitation, aggression, hallucinations (seeing/hearing things that aren't there), delusions (believing things that are not true), or psychosis
• Severe Skin Reactions: Such as Acute Generalised Exanthematous Pustulosis (AGEP) - a rash with pus-filled blisters

Other Side Effects (by frequency)

Very Common (affects more than 1 in 10 people)

• Difficulty sleeping (insomnia)

Common (affects up to 1 in 10 people)

• Headache
• Feeling dizzy, fever, sweating
• Feeling depressed, anxious, or agitated
• Difficulty concentrating
• Tremor (shakiness)
• Dry mouth, feeling sick (nausea), vomiting, stomach pain, constipation, taste changes
• Skin rash, itching

Uncommon (affects up to 1 in 100 people)

• Ringing in the ears, visual disturbances
• Increased blood pressure, flushing
• Loss of appetite, chest pain, rapid heartbeat
• Feeling weak or confused

Rare, Very Rare, and Unknown frequency side effects

Include fainting, muscle stiffness, memory loss, hepatitis, jaundice, and blood cell changes. For a complete list, refer to the official Package Leaflet.

Reporting Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. You can also report them directly via the UK Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

How to Store Zyban

• Keep out of the sight and reach of children
• Do not use after the expiry date printed on the pack
• Store in the original package below 25°C
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use

Zyban Pack Information

Zyban 150 mg tablets are white, film-coated, and round, imprinted with 'GX CH7' on one side. They are supplied in cartons containing blisters of 60 tablets.

Marketing Authorisation Holder

Glaxo Wellcome UK Ltd, UK

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